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Last Updated: February 29, 2024

Acalabrutinib - Generic Drug Details


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What are the generic sources for acalabrutinib and what is the scope of patent protection?

Acalabrutinib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib has one hundred and eighty patent family members in forty-nine countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for acalabrutinib
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for acalabrutinib
Generic Entry Date for acalabrutinib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital of Würzburg, PathologyPhase 3
University of Leipzig, Institute for Medical Informatics, Statistics and Epidemiology (IMISE)Phase 3
University Hospital of Gießen and Marburg, Molecular PathologyPhase 3

See all acalabrutinib clinical trials

Generic filers with tentative approvals for ACALABRUTINIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial100MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acalabrutinib
Drug ClassKinase Inhibitor
Mechanism of ActionTyrosine Kinase Inhibitors
Paragraph IV (Patent) Challenges for ACALABRUTINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CALQUENCE Capsules acalabrutinib 100 mg 210259 5 2021-11-01

US Patents and Regulatory Information for acalabrutinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib maleate TABLET;ORAL 216387-001 Aug 3, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for acalabrutinib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Calquence acalabrutinib EMEA/H/C/005299
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Authorised no no no 2020-11-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for acalabrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2734522 SPC/GB21/019 United Kingdom ⤷  Try a Trial PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/20/1479 (NI) 20201106; UK PLGB 17901/0353 20201106
2734522 CR 2021 00007 Denmark ⤷  Try a Trial PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106
2734522 2021016 Norway ⤷  Try a Trial PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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